Device Classification Name |
cerclage, fixation
|
510(k) Number |
K233949 |
Device Name |
ACCORD Cable System |
Applicant |
Smith & Nephew, Inc. |
1450 Brooks Road |
Memphis,
TN
38116
|
|
Applicant Contact |
Anne Remington |
Correspondent |
Smith & Nephew, Inc. |
1450 Brooks Road |
Memphis,
TN
38116
|
|
Correspondent Contact |
Anne Remington |
Regulation Number | 888.3010
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/14/2023 |
Decision Date | 03/13/2024 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|